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VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities

VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04800757
Enrollment
325
Registered
2021-03-16
Start date
2021-05-11
Completion date
2021-11-02
Last updated
2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Work-related Injury

Keywords

latino day laborers

Brief summary

The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes

Interventions

BEHAVIORALindividual -Brief Motivational Intervention (BMI)

A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge (Mi Promesa) to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey.

BEHAVIORALGroup (Group Problem Solving)

Participants will be administered a baseline survey prior to session. The GPS intervention consists of a discussion between 2-5 LDLs and a trained group facilitator. The sessions will last 30-45 minutes and are intended to encourage and support Latino day laborers (LDL) to act to reduce work-related hazards and promote worksite safety. The intervention combines four participatory and group problem solving activities to engage in collaborative learning: an icebreaker, the risk identification, action planning, and Nuestra Promesa (Our Pledge). The last activity requires LDL to select a risk reduction behavior and then to fill out and sign a card detailing a pledge to implement a safety plan. Follow up surveys will be conducted four weeks post intervention, to assess participants' change in attitudes, beliefs, and risk reducing behavior and their implementation or their safety plan.

BEHAVIORALStandard of Care (OSHA 10 Safety Cards)

Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cluster randomized

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* self-identify as Hispanic or Latino * be present at the corner for the purpose of looking for work

Exclusion criteria

* have not been previously hired to work at a corner * symptoms of COVID-19 in the previous 48 hours

Design outcomes

Primary

MeasureTime frameDescription
Change in Work Hazard Exposure as Assessed by a SurveyBaseline, 4 weeks post interventionTotal score on the work hazard exposure survey ranges from 1 - 4, with a higher score indicating greater work hazard exposures. The data are reported as score at post-intervention minus score at baseline.
Change in Work Conditions as Assessed by a SurveyBaseline, 4 weeks post interventionTotal score on the work conditions survey ranges from 1 - 4, with a higher score indicating greater adverse work conditions. The data are reported as score at post-intervention minus score at baseline.

Secondary

MeasureTime frameDescription
Change in Safety Practices as Assessed by a SurveyBaseline, 4 weeks post interventionThe score for each of the 22 safety practices items ranged from 1-4, with a higher score indicating greater safety practice. The total score for the complete scale consisting of all 22 items is the average of items responded to and also ranged from 1-4. Separate scores for each subscale were computed similarly. The first subscale consisted of eight items; the second consisted of four items, and the third consisted of three items--the score for each subscale ranged from 1-4, with a higher score indicating greater safety practice. There were seven original items that were not associated with the subscales derived from the factor analyses. The data are reported as scores at post-intervention minus scores at baseline.
Number of Participants That Implemented the Safety Plan as Assessed by a Survey4 weeks post interventionParticipants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard of Care
Standard of Care (OSHA 10 Safety Cards): Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy.
112
Individual (Brief Motivational Intervention)
individual -Brief Motivational Intervention (BMI): A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge (Mi Promesa) to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey.
100
Group (Group Problem Solving)
Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan.
106
Total318

Baseline characteristics

CharacteristicStandard of CareTotalGroup (Group Problem Solving)Individual (Brief Motivational Intervention)
Age, Continuous46 years
STANDARD_DEVIATION 12.3
45.6 years
STANDARD_DEVIATION 11.7
46.5 years
STANDARD_DEVIATION 11.3
44.1 years
STANDARD_DEVIATION 11.3
Ethnicity (NIH/OMB)
Hispanic or Latino
112 Participants318 Participants106 Participants100 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
112 Participants318 Participants106 Participants100 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
112 Participants318 Participants106 Participants100 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
112 Participants318 Participants106 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1120 / 1000 / 106
other
Total, other adverse events
0 / 1120 / 1000 / 106
serious
Total, serious adverse events
0 / 1120 / 1000 / 106

Outcome results

Primary

Change in Work Conditions as Assessed by a Survey

Total score on the work conditions survey ranges from 1 - 4, with a higher score indicating greater adverse work conditions. The data are reported as score at post-intervention minus score at baseline.

Time frame: Baseline, 4 weeks post intervention

ArmMeasureValue (MEAN)Dispersion
Standard of CareChange in Work Conditions as Assessed by a Survey-0.21 score on a scaleStandard Error 0.54
Individual (Brief Motivational Intervention)Change in Work Conditions as Assessed by a Survey-0.21 score on a scaleStandard Error 0.49
Group (Group Problem Solving)Change in Work Conditions as Assessed by a Survey-0.38 score on a scaleStandard Error 0.59
Primary

Change in Work Hazard Exposure as Assessed by a Survey

Total score on the work hazard exposure survey ranges from 1 - 4, with a higher score indicating greater work hazard exposures. The data are reported as score at post-intervention minus score at baseline.

Time frame: Baseline, 4 weeks post intervention

ArmMeasureValue (MEAN)Dispersion
Standard of CareChange in Work Hazard Exposure as Assessed by a Survey-0.25 score on a scaleStandard Deviation 0.56
Individual (Brief Motivational Intervention)Change in Work Hazard Exposure as Assessed by a Survey-0.07 score on a scaleStandard Deviation 0.52
Group (Group Problem Solving)Change in Work Hazard Exposure as Assessed by a Survey-0.26 score on a scaleStandard Deviation 0.5
Secondary

Change in Safety Practices as Assessed by a Survey

The score for each of the 22 safety practices items ranged from 1-4, with a higher score indicating greater safety practice. The total score for the complete scale consisting of all 22 items is the average of items responded to and also ranged from 1-4. Separate scores for each subscale were computed similarly. The first subscale consisted of eight items; the second consisted of four items, and the third consisted of three items--the score for each subscale ranged from 1-4, with a higher score indicating greater safety practice. There were seven original items that were not associated with the subscales derived from the factor analyses. The data are reported as scores at post-intervention minus scores at baseline.

Time frame: Baseline, 4 weeks post intervention

ArmMeasureGroupValue (MEAN)Dispersion
Standard of CareChange in Safety Practices as Assessed by a SurveySafety Practices: Proactive Communication-0.16 score on a scaleStandard Deviation 0.93
Standard of CareChange in Safety Practices as Assessed by a SurveySafety Practices: Preparation Safety-0.15 score on a scaleStandard Deviation 0.71
Standard of CareChange in Safety Practices as Assessed by a SurveySafety Practices: Harm Mitigation0.02 score on a scaleStandard Deviation 0.61
Standard of CareChange in Safety Practices as Assessed by a SurveySafety Practices: All Items-0.11 score on a scaleStandard Deviation 0.49
Individual (Brief Motivational Intervention)Change in Safety Practices as Assessed by a SurveySafety Practices: Preparation Safety0.01 score on a scaleStandard Deviation 0.8
Individual (Brief Motivational Intervention)Change in Safety Practices as Assessed by a SurveySafety Practices: Proactive Communication0.04 score on a scaleStandard Deviation 1.13
Individual (Brief Motivational Intervention)Change in Safety Practices as Assessed by a SurveySafety Practices: All Items0.03 score on a scaleStandard Deviation 0.59
Individual (Brief Motivational Intervention)Change in Safety Practices as Assessed by a SurveySafety Practices: Harm Mitigation-0.01 score on a scaleStandard Deviation 0.59
Group (Group Problem Solving)Change in Safety Practices as Assessed by a SurveySafety Practices: Proactive Communication0.10 score on a scaleStandard Deviation 0.9
Group (Group Problem Solving)Change in Safety Practices as Assessed by a SurveySafety Practices: Harm Mitigation0.06 score on a scaleStandard Deviation 0.64
Group (Group Problem Solving)Change in Safety Practices as Assessed by a SurveySafety Practices: All Items0.03 score on a scaleStandard Deviation 0.53
Group (Group Problem Solving)Change in Safety Practices as Assessed by a SurveySafety Practices: Preparation Safety0.01 score on a scaleStandard Deviation 0.73
Secondary

Number of Participants That Implemented the Safety Plan as Assessed by a Survey

Participants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially

Time frame: 4 weeks post intervention

Population: The participants in the standard of care arm did not make a safety plan; therefore, safety plan data were not collected for the standard of care arm. Also, data for this outcome measure were not collected from 34/82 participants in the Brief Motivational Intervention arm and 34/75 participants in the Group Problem Solving arm.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Standard of CareNumber of Participants That Implemented the Safety Plan as Assessed by a SurveyYes0 Participants
Standard of CareNumber of Participants That Implemented the Safety Plan as Assessed by a SurveyNo0 Participants
Standard of CareNumber of Participants That Implemented the Safety Plan as Assessed by a SurveyPartially0 Participants
Individual (Brief Motivational Intervention)Number of Participants That Implemented the Safety Plan as Assessed by a SurveyYes18 Participants
Individual (Brief Motivational Intervention)Number of Participants That Implemented the Safety Plan as Assessed by a SurveyNo5 Participants
Individual (Brief Motivational Intervention)Number of Participants That Implemented the Safety Plan as Assessed by a SurveyPartially25 Participants
Group (Group Problem Solving)Number of Participants That Implemented the Safety Plan as Assessed by a SurveyNo5 Participants
Group (Group Problem Solving)Number of Participants That Implemented the Safety Plan as Assessed by a SurveyPartially12 Participants
Group (Group Problem Solving)Number of Participants That Implemented the Safety Plan as Assessed by a SurveyYes24 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026